Medical Sector. . .
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The medical sector has specific challenges to which Automa8 Ltd has significant experience. Having worked within this specific sector for some 12 years, the important aspects of medical devices: Design for Assembly (DFA), Design for Manufacture (DFM) and design Failure Mode Effect Analysis (dFMEA) have been addressed for a wide variety of devices.
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Intimate knowledge of Dose Powder Inhalers (DPI), pressurised Meter Dose Inhalers (pMDI) and ‘wet’ diagnostic devices has been gained over many years of close liaison with product designers, consultancies and pharmaceutical companies, providing appropriate automation for assembly and verification across the gestation of a device through to full scale production.
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. Whatever basis upon which your drug delivery system is based, it will be enhanced by a pragmatic and clear thinking approach to design robust products and processes from the automation viewpoint . |
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The need for early involvement cannot be over-stressed. As projects develop they gain their own inertia and can limit or prohibit necessary changes when they are best (and most cost effectively) implemented. Ownership of design and the mentality that says ‘it’s too late to change it now’ are potential areas of significant on-cost and time delays as each element becomes ever more entrenched.
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. Early involvement of experienced automation experts will without doubt pay dividends in both time and budgets; call Automa8 Ltd to discuss without commitment
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Development in the last 10 to 15 years of DPIs has meant higher expectations of both pharmaceutical companies (the customer) and also that of the end user (either Point of Care [POC] or patient). This improved ‘user friendliness’ is now encouraging ‘reverse engineering’ of pMDI devices, as they have proven efficacy and are therefore more readily ‘reinvented’ and sold to the patient.
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- Consider device design in relation to assembly and automation and its impact on the robustness of your device (best undertaken at the earliest opportunity)
- Simplify parts as early as possible, make the design intrinsically cost effective during the design stage and save exponentially later in the project.
- The earlier the involvement of Automa8 Ltd, the more likely the project is to run to plan and budget by making necessary decisions early.
- Consider automated checking; what is your philosophy and how is it best applied?
- dFMEA should be undertaken with knowledge of the product functionality along with shortcomings on the processing of the device.
- Validation and 21CFR part 11: this process must be undertaken in a progressive and appropriate manner, using automation suppliers to their best effect with involvement from both parties.